D
Patient 1
THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR EIGHT DIFFERENT SAMPLES FROM THE SAME PATIENT TESTED FOR C-REACTIVE PROTEIN GEN.3 (CRP). THE PATIENT'S PHYSICIAN WAS CONCERNED BECAUSE THE CRP RESULTS WERE CONSIDERED TO BE NEGATIVE, BUT BLOOD CULTURES FOR THIS PATIENT WERE POSITIVE. THE CRP VALUES FROM ALL EIGHT SAMPLES WERE QUESTIONED BY THE PHYSICIAN. SAMPLES WERE TESTED ON 2 DIFFERENT C501 MODULES. THIS MEDWATCH IS FOR REAGENT LOT 68661201 WITH AN EXPIRATION DATE OF (B)(6) 2014 AND USED ON C501 SERIAL NUMBER (B)(4). THE FIRST SAMPLE RESULTED AS 2.0 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE SECOND SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 1.9 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE THIRD SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 2.8 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE FOURTH SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 0.1 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE FIFTH SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 0.2 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE SIXTH SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 1.2 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE SEVENTH SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 0.9 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE EIGHTH SAMPLE, TESTED ON (B)(6) 2014, RESULTED AS 1.1 MG/L ON C501 MODULE SERIAL NUMBER (B)(4). THE PATIENT HAD TWO BLOOD CULTURE SAMPLES THAT WERE DRAWN AT THE SAME TIME ON (B)(6) 2014. ONE BLOOD CULTURE SAMPLE WAS A LINE DRAW AND THE OTHER SAMPLE WAS A PHLEBOTOMY DRAW. THE FINAL RESULTS FOR BOTH CULTURES YIELDED STAPHYLOCOCCUS EPIDERMIDIS. THE PHYSICIAN TREATED THE PATIENT WITH VANCOMYCIN SINCE HE DID NOT BELIEVE THE CRP RESULTS. THE PATIENT IS STILL IN THE HOSPITAL SINCE IT WAS A PREMATURE NEWBORN. THERE WAS A SUBSEQUENT NEGATIVE BLOOD CULTURE RESULT ON (B)(6) 2014, BUT THE PATIENT IS STILL ON VANCOMYCIN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE CUSTOMER DECLINED A SERVICE VISIT.